William J. Sandborn
ORLANDO, Fla. — Etrolizumab, a dual-action, gut-selective anti-integrin antibody, led to endoscopic and symptom improvements in patients with moderate-to-severe Crohn’s disease in the phase 3 BERGAMOT trial, according to a poster presentation at AIBD 2017.
Responders from this induction phase are currently being enrolled in the maintenance phase of development.
To evaluate the safety and efficacy of etrolizumab (RG7413; Genentech) in moderate-to-severe Crohn’s disease, William J. Sandborn, MD, of University of California, San Diego, and colleagues randomly assigned 300 patients (73% of whom were refractory or intolerant to an anti-TNF) to receive one of two dosing regimens of subcutaneous etrolizumab or placebo for 12 weeks.
Both doses of etrolizumab (105 mg and 210 mg) were superior to placebo at improving Crohn’s disease activity index remission rates at weeks 10 (22.5% and 24% vs. 10.2%) and 14 (23.3% and 28.9% vs. 16.9%). In addition, the drug was superior to placebo at improving PRO2 remission rates — which are “patient-reported measures of disease activity now recommended by health authorities” — at weeks 6, 10 and 14.
However, “PRO2 did not accomplish the intended goal of identifying an endpoint specific to Crohn’s disease that reduces placebo rates,” Sandborn and colleagues noted.
Notably, patients achieved symptomatic improvement with both doses as early as week 6 (15% and 25.6% vs. 8.5%), and this was maintained throughout week 14 (20.8% and 24.8% vs. 11.9%).
Finally, both doses led to “clinically meaningful” endoscopic improvement “as assessed by a rigorous central reading model” (at least a 50% improvement from baseline) at week 14 (21% and 17.4% vs. 3.4%).
The drug was well tolerated and adverse events occurred in comparable proportions in all groups. The most common infection was nasopharyngitis and this occurred more often with the study drug (6.6% vs. 3.4%). – by Adam Leitenberger
Sandborn WJ, et al. Abstract P-011. Presented at: Advances in IBD; Nov. 9-11, 2017; Orlando, Fla.
Disclosures: Sandborn reports financial relationships with Genentech and numerous other disclosures, which can be viewed in the AIBD program.